U.S. PHARMACOPEIA

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Aztreonam Injection
» Aztreonam Injection is a sterile solution of Aztreonam and Arginine and a suitable osmolality adjusting substance in Water for Injection. It contains not less than 90.0 percent and not more than 120.0 percent of the labeled amount of aztreonam (C13H17N5O8S2).
Packaging and storage— Preserve in Containers for Sterile Solids as described under Injections 1. Maintain in the frozen state.
Labeling— It meets the requirements for Labeling under Injections 1. The label states that it is to be thawed just prior to use, describes conditions for proper storage of the resultant solution, and directs that the solution is not to be refrozen.
Identification— The retention times of the major peaks in the chromatogram of the Assay preparation correspond to those of the Standard preparation, as obtained in the Assay.
Pyrogen 151— It meets the requirements, the test dose being an accurately measured volume of Injection sufficient to provide 50 mg of aztreonam per kg.
Sterility 71— It meets the requirements when tested as directed for Membrane Filtration under Test for Sterility of the Product to be Examined.
pH 791: between 4.5 and 7.5.
Particulate matter 788: meets the requirements for small-volume injections.
Residual solvents 467: meets the requirements.
(Official January 1, 2007)
Assay—
Mobile phase, Standard preparation, Resolution solution, and Chromatographic system— Prepare as directed in the Assay under Aztreonam for Injection.
Assay preparation— Dilute an accurately measured volume of Injection quantitatively with Mobile phase to obtain a solution containing about 0.2 mg of aztreonam per mL.
Procedure— Proceed as directed for Procedure in the Assay under Aztreonam for Injection. Calculate the quantity, in mg, of aztreonam (C13H17N5O8S2) in the volume of Injection taken by the formula:
(CS PS L / 1000D)(rU / rS),
in which CS is the concentration, in mg per mL, of USP Aztreonam RS in the Standard preparation; PS is the assigned purity, in µg per mg, of USP Aztreonam RS; L is the labeled quantity, in mg, of aztreonam (C13H17N5O8S2) in the volume of Injection taken; D is the concentration, in mg of aztreonam per mL, based on the labeled quantity in the volume of Injection taken; and rU and rS are the aztreonam peak responses obtained from the Assay preparation and the Standard preparation, respectively.
Auxiliary Information— Staff Liaison : Brian D. Gilbert, Ph.D., Scientist
Expert Committee : (MDANT05) Monograph Development-Antibiotics
USP29–NF24 Page 230
Phone Number : 1-301-816-8223